Real-world experience of children with growth hormone deficiency who switched from daily growth hormone to the Long-Acting Growth Hormone Somatrogon

Study type

• Study topic:
  Other
• Study topic, other:
  Paediatric growth disorders/Growth Hormone Deficiency treatment in children
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  GENOTROPIN

  NGENLA
• Study drug International non-proprietary name (INN) or common name:
  SOMATROGON

  SOMATROPIN
• Anatomical Therapeutic Chemical (ATC) code:
  (H01AC08) somatrogon

  somatrogon

  (H01AC01) somatropin

  somatropin
• Medical condition to be studied:
  Growth hormone deficiency

Population studied

• Short description of the study population:
  The target population consists of patients who transitioned from daily GH therapy to weekly somatrogon, a long-acting hGH treatment, as prescribed by their treating physician in routine clinical practice. The source population includes patients from the Maccabi HCO database in Israel and the REPAR registry in the Czech Republic. Eligible patients are male or female, up to 17 years old at the start of the pre-index period, with at least 6 months of data on daily GH treatment (somatropin) and a minimum of 6 months of follow-up data after switching to long-acting somatrogon.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  450